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Curcumin in Treating Patients With Familial Adenomatous Polyposis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00641147
First received: March 17, 2008
Last updated: November 22, 2016
Last verified: November 2016

March 17, 2008
November 22, 2016
October 2010
November 2016   (final data collection date for primary outcome measure)
  • Change in activation of NFKB pathway [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Change in Akt phosphorylation levels [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Change in apoptosis index levels [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Change in Ki-67 anti-proliferative cell nuclear antibody index levels [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Change in mucosa and adenoma histology assessed by light microscopy [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Change in mucosal DNA methylation levels [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Change in mucosal leukotriene levels [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Change in mucosal prostaglandin levels [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Change in ODC activity levels expressed as nmol of activity/mg of musosal tissue/hr [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Change in polyamines levels expressed pg/mg protein [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Change in vascular density [ Time Frame: Baseline to up to 12 months ] [ Designated as safety issue: No ]
  • Incidence of grade >= 2 adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    A safety review will be performed at the time of interim analysis.
  • Mean polyp size in mm (mean size of the 5 largest polyps) [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]
    Continuous variables relating to colorectal proliferation and polyp size will be compared in the two treatment groups by parametric statistics.
  • Medication compliance [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Number of patients failing study [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]
  • Side effects of curcumin treatment [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Total number of polyps [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]
    The average number of polyps in the treatment groups will be compared by the t-test (or a distribution free analog if distribution assumptions are not met). Multivariate regression models will be used to adjust for strongly predictive factors that are not balanced in the treatment groups.
polyp number and size [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00641147 on ClinicalTrials.gov Archive Site
Not Provided
side effects and medication compliance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Curcumin in Treating Patients With Familial Adenomatous Polyposis
Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
This randomized phase II trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.

PRIMARY OBJECTIVES:

I. To determine in a randomized, double-blinded, placebo-controlled study the tolerability and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in familial adenomatous polyposis patients with intact colons, ileorectal anastomosis surgery, or ileo-anal pullthrough (reservoir) surgery.

II. To measure markers of cell proliferation including colorectal mucosal levels of ornithine decarboxylase (ODC), polyamines, mucosal deoxyribonucleic acid (DNA) methylation, proliferative index (Ki67 antiproliferative cell nuclear antibody), apoptosis index, vascular density, mucosal prostaglandin, leukotriene levels, and activation of the nuclear factor kappa B (NFKB), and v-akt murine thymoma viral oncogene homolog 1 (Akt) survival pathways.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive curcumin orally (PO) twice daily (BID) for 12 months.

ARM II: Patients receive placebo PO BID for 12 months.

After completion of study treatment, patients are followed up at 4 months.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Familial Adenomatous Polyposis
  • Drug: Curcumin
    Given PO
    Other Names:
    • C.I. 75300
    • C.I. Natural Yellow 3
    • Diferuloylmethane
    • Turmeric Yellow
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Placebo
    Given PO
    Other Names:
    • placebo therapy
    • PLCB
    • sham therapy
  • Experimental: Arm I (curcumin)
    Patients receive curcumin PO BID for 12 months.
    Interventions:
    • Drug: Curcumin
    • Other: Laboratory Biomarker Analysis
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO BID for 12 months.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
Not Provided
November 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total coloctomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir
  • Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy

Exclusion Criteria:

  • Female patients of childbearing age not on effective birth control
  • Pregnant women
  • White blood cell count (WBC) < 3500/ml
  • Platelet count < 100,000/ml
  • Blood urea nitrogen (BUN) > 25mg%
  • Creatinine > 1.5mg%
  • Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial
  • Malignancy other than nonmelanoma skin cancer
  • Active bacterial infection
  • Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy)
  • Patients with a history of peptic ulcer disease
  • Patients on warfarin or plavix
Both
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00641147
NCI-2013-00536, NCI-2013-00536, CDR0000592794, NA_00011821, 00011821, 1R01CA134620, R01CA134620, P30CA006973
Yes
Not Provided
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Francis Giardiello Johns Hopkins University/Sidney Kimmel Cancer Center
National Cancer Institute (NCI)
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP